# FDA 483 - Diego F. Montes, M.D. - October 06, 2025

Source: https://www.keypedia.com/records/483/diego-f-montes-md/db842fd6-f615-48f6-9020-ea706985d9fa

> FDA 483 for Diego F. Montes, M.D. on October 06, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diego F. Montes, M.D.
- Inspection Date: 2025-10-06
- Product Type: other
- Office Name: Florida District Office
- Summary: An FDA inspection of Medgate Life Sciences Group, Corp. in Pembroke Pines, FL, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans and inclusion criteria, as well as issues with maintaining accurate case histories and informed consent forms. These findings indicate serious concerns regarding data integrity and subject protection in their clinical trials.

## Related Officers

- [Chantae D. Mitchell](https://www.keypedia.com/people/chantae-d-mitchell/0da68244-86f3-4119-b965-0b2dceb1c523)

Company: https://www.keypedia.com/companies/diego-f-montes-md/6d454660-28f7-4cdd-905c-d11374a47895

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9